01 1Sanwa Chemical Industrial
02 1Sifavitor srl
01 2CYCLANDELATE
01 1Hong Kong
02 1Italy
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2564
Submission : 1975-11-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3292
Submission : 1978-09-15
Status : Inactive
Type : II
A Cyclandelate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyclandelate, including repackagers and relabelers. The FDA regulates Cyclandelate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyclandelate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Cyclandelate supplier is an individual or a company that provides Cyclandelate active pharmaceutical ingredient (API) or Cyclandelate finished formulations upon request. The Cyclandelate suppliers may include Cyclandelate API manufacturers, exporters, distributors and traders.
click here to find a list of Cyclandelate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cyclandelate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cyclandelate active pharmaceutical ingredient (API) in detail. Different forms of Cyclandelate DMFs exist exist since differing nations have different regulations, such as Cyclandelate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cyclandelate DMF submitted to regulatory agencies in the US is known as a USDMF. Cyclandelate USDMF includes data on Cyclandelate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cyclandelate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cyclandelate suppliers with USDMF on PharmaCompass.
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